FDA Adverse Event
Malfunction
Summary report: N
SURESET 3.0 ML RESERVOIR
MDR report key: 2382014
·
Received November 1, 2011
Report
- Report Number
- 3004145981-2011-00001
- Event Type
- Malfunction
- Date Received
- November 1, 2011
- Date of Event
- September 27, 2007
- Report Date
- November 1, 2010
- Manufacturer
- APPLIED DIABETES RESEARCH, INC.
- Product Code
- FRN
- PMA / PMN Number
- K024056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE USER INFORMED THAT HE FOUND LEAKING AT THE LUER CONNECTION BETWEEN THE RESERVOIR AND INFUSION SET WHEN HE INSTALLED NEW RESERVOIR AND INFUSION SET INTO HIS INSULIN PUMP. HE COULD NOT DETERMINE WHERE THE LEAKING CAME FROM. HIS BLOOD SUGAR LEVELS WERE IN HIS NORMAL RANGE OF 110-135. HE CHECKS BLOOD SUGAR 4-5 TIMES DAILY. WHEN ASKED, THE USER STATED NO OTHER INTERVENTION WAS NEEDED AFTER THE EVENT. AFTER INVESTIGATION, THE USER AGREED THAT THE LUER LOCK MAY NOT HAVE BEEN TIGHTEN PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURESET 3.0 ML RESERVOIR | INFUSION PUMP SYRINGE | FRN | APPLIED DIABETES RESEARCH, INC. | 103A | 73414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |